SUPPLY CHAIN ARTICLES

  • 5 Critical Regulatory Topics To Watch In The Oligo Sector

    Though our guidances have helped us achieve upwards of 20 commercially approved oligo products, as I listened to GSK’s director of CMC policy and advocacy, Katie Duncan, present at TIDES, it struck me just how far we have yet to come. Here, I single out a few of the biggest topics of regulatory discussion shaping the oligo therapeutics market.

  • FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

  • How Can We Move RNA Forward In Our Therapeutics Arsenal?

    RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality. However, they have unique challenges. BioPhorum has dedicated a team to investigate these challenges and this Q&A shares their practical considerations for how to move this field forward.

  • Plasmid Production: 3 Key Takeaways For mRNA Manufacturing

    Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid. 

  • “Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA

    It goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).

  • Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned

    One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain. 

SUPPLY CHAIN VIDEOS

Advancing RNA Live panelists delve into advancements in IVT technology, homing in on innovations like bead-based purification, improved enzymes, and modular manufacturing systems.

Three LNP experts share their thoughts on the incremental advancements they’d like to see the RNA-LNP space make in the next few years.

Explore critical steps and key regulatory requirements for developing CRISPR therapeutics and gain practical advice on how to avoid common pitfalls.

In this opening Advancing RNA Live clip, NanoVation Therapeutics’ Dominik Witzigmann and Stealth Co’s John Zuris share the scientific advancements they’ve been watching most keenly in the LNP space, as well as some of the evolutions they’re seeing in the overall quality of our RNA-LNP products.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS